- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07591571
To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC
To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC With a Pilot Randomized Controlled Trial of 60 PDAC Patients and Their Caregivers Comparing the Intervention to Attention Control With Usual Care.
The goal of this clinical trial is to learn if a community health worker led intervention that helps facilitate palliative care works to treat newly-diagnostic pancreatic cancer. It will also help understand the impact of this intervention on people who are caregivers for patients with pancreatic cancer. The main questions it aims to answer are:
Does the community health worker improve symptoms and quality of life in patients with pancreatic cancer? Does the community health worker improve the burden of caregiving and quality of life in family caregivers? Researchers will compare drug ABC to a control (where patients get the care that patients with pancreatic cancer receive including access to handouts and videos that the investigators provide patients by national organizations) to see if the intervention works to help patients with pancreatic cancer.
Participants will:
Meet with study staff several times over 3 months and complete surveys about their experience and symptoms Patients assigned with the community health worker will meet with them in person or video.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
d. Overall study design
This will be a pilot randomized controlled trial where the investigators will plan on randomizing patients with PDAC in a 1:1 fashion to receive a digitally-enhanced community health worker intervention that will involve visits with the CHW and digital communication to facilitate care navigation and provide early palliative care engagement or usual care.
e. Study Procedures and Schedule
Recruitment of subjects for the study
To recruit patients for the interviews, the investigators will screen all of the patients who present for endoscopic ultrasound (with biopsy) to the endoscopy unit or pre-procedure clinic at Loma Linda, as well as patients referred to the medical or surgical oncology clinics with a new diagnosis of pancreatic adenocarcinoma. The investigators will recruit patients from our gastroenterology clinic and endoscopic unit and the oncology clinic (the researcher's patients) both in person and over the phone via a telephone call. The investigators will not contact patients outside our clinical practice but will distribute an IRB-approved flyer with our number to oncology clinics that patients can call and leave a voicemail or email us at our secure HIPPA-complaint Loma Linda email address assigned to our study (cancerresearch@llu.edu). The investigators will also distribute an IRB-approved letter to other oncologists informing them of the study so they can distribute the flyer to their patients and inform patients who may be candidates for this study. The reason the investigators are including patients with suspected PDAC is to eliminate delays once they receive a diagnosis as patients previously reported a flurry of medical visits in the 2 weeks after diagnosis. However, patients will need to undergo a biopsy and have pathology confirmation before study initiation. Patients found to have other pathology on biopsy than pancreatic adenocarcinoma will be excluded. The investigators will explain the study inperson or over the phone when they are referred for a pancreatic biopsy or for oncologic care for a new diagnosis of pancreatic cancer. The investigators will explain that the investigators are recruiting them because they have pancreatic cancer and want to study if a community health worker can help patients like themselves navigate care and engage with palliative care better than the current care that patients receive. If they are interested, they will then be consented using written informed consent at their clinic visit in the clinic or prior to their in-person study visit.
When a patient is diagnosed with PDAC, they receive the diagnosis over the phone and follow-up in clinic. They are referred to medical and surgical oncology and to palliative care for supportive care..
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nikhil Thiruvengadam, MD
- Número de teléfono: 9095584668
- Correo electrónico: nthiruvengadam@llu.edu
Ubicaciones de estudio
-
-
California
-
Loma Linda, California, Estados Unidos, 92886
- Reclutamiento
- Loma Linda University Health
-
Contacto:
- Nikhil Thiruvengadam, MD
- Número de teléfono: 9095584668
- Correo electrónico: nthiruvengadam@llu.edu
-
Contacto:
- Susanne Montgomery, PhD
- Número de teléfono: 9095584668
- Correo electrónico: smontgomery@llu.edu
-
Investigador principal:
- Nikhil Thiruvengadam, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Age 18 to 90
- English or Spanish-Speaking
- Diagnosed with Newly-Diagnosed Pancreatic Adenocarcinoma or has a pancreatic mass on CT/MRI with suspected PDAC and is awaiting biopsy.
- Able to communicate verbally to allow for audio recording to complete an exit interview
- Must be able to consent
Exclusion criteria:
• Biopsy Does not Confirm Adenocarcinoma of the Pancreas
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Community Health Worker Intervention
They work with the community health worker to monitor symptoms and escalate palliative care visits as needed, receive care navigation and disease education
|
The intervention involves meeting with a community health worker who will address quality of life concerns, including physical, spiritual, social, and psychological concerns, help patients schedule visits, and set them up to receive telehealth.
They also monitor their symptoms via weekly text messages and receive help managing them.
Finally, they help patients complete advanced care planning.
|
|
Comparador activo: Attention Control with Usual Care
They receive usual care at our institution, including a referral to palliative care at diagnosis, referrals to oncology and medical oncology, and also the handouts from PANCAN provided in clinic, and access to videos from the National Pancreas Foundation.
|
This involves usual care at our institution, including referrals to medical oncology, surgical oncology, and palliative care but they also receive attention from the study coordinator completing 3 visits including survey instruments and are provided standard of care written and media-based materials from PANCAN and the National Pancreas Foundation.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index
Periodo de tiempo: 12 weeks
|
This score goes from 0 to 72 with higher scores being better.
It measures the symptom burden in pateints with pancreatic, biliary and liver cancers.
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Assessment of Cancer Therapy Hepatobiliary
Periodo de tiempo: 12 weeks
|
The FACT-Hep score measures quality of life in patients with pancreatic, biliary and liver cancers.
The total score ranges from 0 to 180, with higher scores indicating better quality of life.
|
12 weeks
|
|
Preparedness for Caregiving Scale
Periodo de tiempo: 12 weeks
|
The score ranges from 0 to 5 and represents the mean of 8 questions.
A higher score is better.
It is designed to capture caregiver preparedness.
|
12 weeks
|
|
City of Hope Caregiver QoL Instrument
Periodo de tiempo: 12 weeks
|
This instrument score represents a mean of subscores and ranges from 0 to 10 with a higher score indicating better caregiver QoL
|
12 weeks
|
|
Goal Concordant Care
Periodo de tiempo: 12 weeks
|
This outcome will not be determined quantitatively but rather qualitatively by conducting interviews with the patient and caregiver (only the caregiver if the patient dies prior to 12 weeks).
Thematic analyses will be peformed with the goal of identifying if the patient and caregiver feel that the care they received reflected their treatment goals.
|
12 weeks
|
|
National Comprehensive Cancer Network Distress Thermometer for Patients
Periodo de tiempo: 12 weeks
|
This measures psychological distress in pateints and scores from 0 to 10, with a lower score being better, i.e., representing lower levels of psychological distress.
|
12 weeks
|
|
National Comprehensive Cancer Center Distress Thermometer for Caregivers
Periodo de tiempo: 12 weeks
|
This measures psychological distress in caregivers and yields scores from 0 to 10, with lower scores indicating lower levels of psychological distress.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, Kochman ML. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity. Clin Gastroenterol Hepatol. 2023 May;21(5):1233-1242.e14. doi: 10.1016/j.cgh.2022.08.034. Epub 2022 Sep 6.
- Chung V, Sun V, Ruel N, Smith TJ, Ferrell BR. Improving Palliative Care and Quality of Life in Pancreatic Cancer Patients. J Palliat Med. 2022 May;25(5):720-727. doi: 10.1089/jpm.2021.0187. Epub 2021 Oct 26.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5250314
- PA230343 (Otro número de subvención/financiamiento: DOD/CDMRP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .